SUMMARY OF CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES | NOTE 3 – SUMMARY OF CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES Basis of Presentation The accompanying condensed consolidated financial statements are unaudited. The unaudited interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("GAAP") and pursuant to the rules and regulations of the Securities and Exchange Commission (the "SEC"). Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations, although the Company believes that the disclosures made are adequate to make the information not misleading. These interim financial statements as of and for the three and nine months ended September 30, 2018 and 2017 are unaudited; however, in the opinion of management, such statements include all adjustments (consisting of normal recurring accruals) necessary to present fairly the financial position, results of operations and cash flows of the Company for the periods presented. The results for the three and nine months ended September 30, 2018 are not necessarily indicative of the results to be expected for the year ending December 31, 2018 or for any future period. All references to September 30, 2018 and 2017 in these footnotes are unaudited. These unaudited condensed financial statements should be read in conjunction with our audited financial statements and the notes thereto for the year ended December 31, 2017, included in the Company's annual report on Form 10-K filed with the SEC on April 26, 2019. The condensed balance sheet as of December 31, 2017 has been derived from the audited financial statements at that date but do not include all disclosures required by the accounting principles generally accepted in the United States of America. Certain items have been reclassified to conform to the current period presentation. Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying disclosures. Significant estimates include the fair value of derivative instruments, stock-based compensation, recognition of clinical trial costs and other accrued liabilities. Actual results may differ from those estimates. Research and Development Research and development costs are charged to expense as incurred. Our research and development expenses consist primarily of expenditures for toxicology and other studies, manufacturing, clinical trials, compensation and consulting costs. We incurred research and development expenses of approximately $0.01 million and $0.4 million for the three months ended September 30, 2018 and 2017, respectively. We incurred research and development expenses of approximately $0.2 million and $1.3 million for the nine months ended September 30, 2018 and 2017, respectively. Cash Equivalents For purposes of the statements of cash flows, we consider all highly liquid debt instruments purchased with a maturity date of three months or less to be cash equivalents. We maintain our cash in bank deposit accounts which, at times, may exceed applicable government mandate insurance limits. We have not experienced any losses in our accounts. Restricted Cash Restricted cash consists of funds held in trust for the Company. The use of these funds is restricted to: (i) the payment of professional fees in connection with bringing the Company's filings current, and (ii) the payment of vendors associated with the issuance and trading of the Company's securities, such as transfer agent fees and fees payable to the OTCQB and FINRA. Loss per Share Basic loss per share is calculated by dividing net loss and net loss attributable to common shareholders by the weighted average number of common shares outstanding for the period. Basic and diluted loss per share are the same, in that any potential common stock equivalents would have the effect of being anti-dilutive in the computation of net loss per share. The following potentially dilutive securities have been excluded from the computations of weighted average shares outstanding as of September 30, 2018 and 2017, as they would be anti-dilutive: Nine Months Ended 2018 2017 Shares underlying options outstanding 325,333 364,516 Shares underlying warrants outstanding 2,512,930 4,511,914 Shares underlying convertible notes outstanding 572,882,313 34,835,228 Shares underlying convertible preferred stock outstanding 26,395,624 4,770,370 376,916,512 44,482,028 Derivative Liability The Company has financial instruments that are considered derivatives or contain embedded features subject to derivative accounting. Embedded derivatives are valued separately from the host instrument and are recognized as derivative liabilities in the Company's balance sheet. The Company measures these instruments at their estimated fair value and recognizes changes in their estimated fair value in results of operations during the period of change. The Company values its derivative liabilities using the Black-Scholes option valuation model. The resulting liability is valued at each reporting date and the change in the liability is reflected as change in derivative liability in the statement of operations. Fair Value of Financial Instruments Our short-term financial instruments, including cash, accounts payable and other liabilities, consist primarily of instruments with maturities of three months or less when acquired. We believe that the fair values of our current assets and current liabilities approximate their reported carrying amounts. The derivative liability consists of our convertible notes with a variable conversion feature. The Company uses the Black-Scholes option-pricing model to value its derivative liability which incorporate the Company's stock price, volatility, U.S. risk-free interest rate, dividend rate, and estimated life. Fair Value Measurements The U.S. GAAP Valuation Hierarchy establishes a valuation hierarchy for disclosure of the inputs to valuation used to measure fair value. This hierarchy prioritizes the inputs into three broad levels as follows. Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 inputs are unobservable inputs based on our own assumptions used to measure assets and liabilities at fair value. A financial asset or liability's classification within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement. The Company has recorded a derivative liability for its convertible notes with a variable conversion feature as of September 30, 2018. The tables below summarize the fair values of our financial liabilities as of September 30, 2018 (in thousands): Fair Value at Fair Value Measurement Using 2018 Level 1 Level 2 Level 3 Derivative liability $ 4,724 $ — $ — $ 4,724 The reconciliation of the derivative liability measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows (in thousands): Nine months ended 2018 2017 Balance at beginning of year $ 2,934 $ — Additions to derivative instruments 577 2,953 Reclassification on conversion (133 ) (44 ) Loss (gain) on change in fair value of derivative liability 1,346 (201 ) Balance at end of period $ 4,724 $ 2,708 Stock-Based Compensation We measure the cost of employee services received in exchange for equity awards based on the grant-date fair value of the awards. All awards under our stock-based compensation programs are accounted for at fair value and that cost is recognized over the period during which an employee is required to provide service in exchange for the award (the vesting period). Compensation expense for options granted to non-employees is determined in accordance with the fair value of the consideration received or the fair value of the equity instruments issued, whichever is a more reliable measurement. Compensation expense for awards granted to non-employees is re-measured on each accounting period. Determining the appropriate fair value of stock-based compensation requires the input of subjective assumptions, including the expected life of the stock-based compensation and the volatility of our stock price. We use the Black-Scholes option-pricing model to value our stock option awards which incorporates our stock price, volatility, U.S. risk-free interest rate, dividend rate, and estimated life. Effect of ASU No. 2017-11 on Previously Issued Financial Statements In July 2017, the Financial Accounting Standards Board ("FASB") issued ASU No. 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480) and Derivatives and Hedging (Topic 815): Part 1 – Accounting for Certain Financial Instruments with Down Round Features and Part 2 – Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with Scope Exception ("ASU No. 2017-11"). Part 1 of ASU No. 2017-11 addresses the complexity of accounting for certain financial instruments with down round features. Down round features are provisions in certain equity-linked instruments (or embedded features) that result in the strike price being reduced on the basis of the pricing of future equity offerings. Current accounting guidance creates cost and complexity for entities that issue financial instruments (such as warrants and convertible instruments) with down round features that require fair value measurement of the entire instrument or conversion option. Part II of ASU No. 2017-11 addresses the difficulty of navigating Topic 480, Distinguishing Liabilities from Equity, because of the existence of extensive pending content in the FASB Accounting Standards Codification®. This pending content is the result of the indefinite deferral of accounting requirements about mandatorily redeemable financial instruments of certain nonpublic entities and certain mandatorily redeemable noncontrolling interests. For public business entities, the amendments in Part I of this update are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. The Company has early adopted the guidance under ASU 2017-11 for the year end December 31, 2017. Adjustments to the Company's previously issued financial statements were required for the full retrospective application of this standard. As such the financial statements for the three and nine months ended September 30, 2017 have been adjusted to reflect the adoption of ASU 2017-11. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (in thousands, except share and per share data) September 30, 2017 As reported Adjustments Adjusted ASSETS Current assets: Cash and cash equivalents $ 18 $ — $ 18 Prepaid expenses 16 — 16 Total current assets 34 — 34 Office and lab equipment, net of accumulated depreciation of $10 350 — 350 Intangible assets, net of accumulated amortization of $158 54 — 54 Goodwill 2,159 — 2,159 Other assets 3 — 3 Total assets $ 2,600 $ — $ 2,600 LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities: Accounts payable $ 1,724 $ — $ 1,724 Accrued expenses 1,093 — 1,093 Convertible debentures, net of unamortized discount of $307 2,480 — 2,480 Derivative liability 3,338 (630 ) 2,708 Total current liabilities 8,635 (630 ) 8,005 Total liabilities 8,635 (630 ) 8,005 Commitments and contingencies — — — Stockholders' deficit: Convertible preferred stock, par value $.0001 per share; 30,000,000 shares authorized, 495 shares issued and outstanding — — — Common stock, par value $.0001 per share; 150,000,000 shares authorized, 9,075,589 shares issued and outstanding 1 — 1 Additional paid-in capital 48,425 2,321 50,746 Accumulated deficit (54,461 ) (1,691 ) (56,152 ) Total stockholders' deficit (6,035 ) 630 (5,405 ) Total liabilities and stockholders' deficit $ 2,600 $ — $ 2,600 CONDENSED STATEMENTS OF LOSSES (unaudited) (in thousands, except share and per share data) Three Months Ended Nine Months Ended Reported Adjustments Adjusted Reported Adjustments Adjusted Operating expenses: Research and development $ 384 — $ 384 $ 1,349 $ — $ 1,349 General and administrative 474 — 474 1,255 — 1,255 Total operating expenses 858 — 858 2,604 — 2,604 Loss from operations (858 ) — (858 ) (2,604 ) — (2,604 ) Other income (expense): Gain on change in fair value of derivative liability 1,405 (1,204 ) 201 3,403 (3,202 ) 201 Gain on conversion of debt 39 — 39 39 — 39 Interest income (expense), net (5,017 ) (137 ) (5,154 ) (6,479 ) 1,325 (5,154 ) Loss before provision for income taxes (4,431 ) (1,341 ) (5,772 ) (5,641 ) (1,877 ) (7,518 ) Provision for income taxes — — — — — — Net loss (4,431 ) (1,341 ) (5,772 ) (5,641 ) (1,877 ) (7,518 ) Deemed dividend — (435 ) (435 ) — (1,703 ) (1,703 ) Net loss attributable to common shareholders $ (4,431 ) $ (1,776 ) $ (6,207 ) $ (5,641 ) $ (3,580 ) $ (9,221 ) Net loss per common share, basic and diluted $ (0.69 ) $ (0.96 ) $ (1.77 ) $ (2.90 ) Weighted average shares outstanding 6,440,802 6,440,802 3,183,289 3,183,289 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) (in thousands) Nine Months Ended September 30, 2017 Reported Adjustments Adjusted Cash flows from operating activities: Net loss $ (5,641 ) $ (1,877 ) $ (7,518 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 23 23 Stock-based compensation 179 179 Gain on change in fair value of derivative liability (3,403 ) 3,202 (201 ) Gain on conversion of debt (39 ) (39 ) Amortization of debt discount 13 13 Finance cost 6,463 (1,325 ) 5,138 Increase in operating assets: Prepaid expenses 100 100 Increase in operating liabilities: Accounts payable and accrued expenses 1,221 1,221 Cash used in operating activities (1,084 ) — (1,084 ) Cash flows from investing activities: Cash from acquisition 23 23 Acquisition of office equipment (3 ) (3 ) Cash provided by investing activities 20 — 20 Cash flows from financing activities: Proceeds from convertible notes 250 250 Proceeds from sale of stock and warrants 285 285 Cash provided by financing activities 535 — 535 Net decrease in cash (529 ) (529 ) Cash, beginning of period 547 547 Cash, end of period $ 18 $ — $ 18 Recent Accounting Pronouncements With the exception of those discussed below, there have not been any recent changes in accounting pronouncements and Accounting Standards Update (ASU) issued by the Financial Accounting Standards Board (FASB) during the nine months ended September 30, 2018 that are of significance or potential significance to the Company. In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases. The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company does not expect any impact from the adoption of this standard on its consolidated financial statements. In January 2017, the FASB issued ASU No. 2017-04, Intangibles-Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment ("ASU No. 2017-04"). ASU No. 2017-04 simplifies the subsequent measurement of goodwill by eliminating Step 2 from the goodwill impairment test. A public business entity that is a SEC filer should adopt the amendments of ASU No. 2017-04 for its annual and interim goodwill impairment tests in fiscal years beginning after December 15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company does not expect any impact from the adoption of this standard on its consolidated financial statements. In May 2017, the FASB issued ASU 2017-09, "Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting", which clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award changes as a result of the change in terms or conditions. If an award is not probable of vesting at the time a change is made, the new guidance clarifies that no new measurement date will be required if there is no change to the fair value, vesting conditions, and classification. This ASU will be applied prospectively and is effective for fiscal years beginning after December 15, 2017, and interim periods within those years, with early adoption permitted. The adoption of this standard did not have a material impact on its consolidated financial statements. In July 2017, the Financial Accounting Standards Board ("FASB") issued ASU No. 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480) and Derivatives and Hedging (Topic 815): Part 1 – Accounting for Certain Financial Instruments with Down Round Features and Part 2 – Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with Scope Exception ("ASU No. 2017-11"). Part 1 of ASU No. 2017-11 addresses the complexity of accounting for certain financial instruments with down round features. Down round features are provisions in certain equity-linked instruments (or embedded features) that result in the strike price being reduced on the basis of the pricing of future equity offerings. Current accounting guidance creates cost and complexity for entities that issue financial instruments (such as warrants and convertible instruments) with down round features that require fair value measurement of the entire instrument or conversion option. Part II of ASU No. 2017-11 addresses the difficulty of navigating Topic 480, Distinguishing Liabilities from Equity, because of the existence of extensive pending content in the FASB Accounting Standards Codification®. This pending content is the result of the indefinite deferral of accounting requirements about mandatorily redeemable financial instruments of certain nonpublic entities and certain mandatorily redeemable noncontrolling interests. For public business entities, the amendments in Part I of this update are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. The Company has early adopted the guidance under ASU 2017-11 for the year end December 31, 2017. Adjustments to the Company's previously issued financial statements were required for the full retrospective application of this standard. As such the financial statements for the three and nine months ended September 30, 2017 have been adjusted to reflect the adoption of ASU 2017-11. |